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Title

Kurtzke Functional System Scores (KFSS)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

KFSS

QRS Permission StatusPublic Domain
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.01
StatusFinalRevision Draft
Date20212022-0409-0329
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


Revision History

Date

Version

Summary of Changes

2021

2022-

04

09-

03

29

2.

0
  • This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
  • The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
  • The example replaced the RSBLFL variable with RSLOBXFL.
  • Updated assumption 4 on the handling of results for RSTESTCD = "KFSS108" and "KFSS108A" and updated the example accordingly.
  • Updated the example description for clarity and included the representation that at visit 2, the instrument was not conducted.

1 Revision Draft

  • Added the description of the relationship between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are intended to be used in conjunction with one another in section 3.1 Assumptions for the RS Domain Model.

2021-04-03

2.0

  • This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
  • The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
  • The example replaced the RSBLFL variable with RSLOBXFL.
  • Updated assumption 4 on the handling of results for RSTESTCD = "KFSS108" and "KFSS108A" and updated the example accordingly.
  • Updated the example description for clarity and included the representation that at visit 2, the instrument was not conducted.

2014-02-19

1.1

2014-02-19

1.1

Kurtzke Functional Systems Scores (KFSS) Revised

  • Added “Other Functions” category to the CRF, resulting in two additional QSTESTCDs (KFSS108 and KFSS108A).
  • Added Assumption 4 specifying how to record responses to KFSS108A.
  • Modified wording of answer choices on CRF to match wording in reference article.
  • Modified Assumptions 1 and 3 to reflect the updated CRF.
2013-11-131.0

Kurtzke Functional Systems Scores (KFSS)

...

Revised

  • Added “Other Functions” category to the CRF, resulting in two additional QSTESTCDs (KFSS108 and KFSS108A).
  • Added Assumption 4 specifying how to record responses to KFSS108A.
  • Modified wording of answer choices on CRF to match wording in reference article.
  • Modified Assumptions 1 and 3 to reflect the updated CRF.
2013-11-131.0Kurtzke Functional Systems Scores (KFSS)


© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 


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1 Introduction

This document describes the CDISC implementation of the Kurtzke Functional System Scores (KFSS) instrument.

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The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each functional system in either a 7-point, 6-point or 2-point scale. The functional systems included in the KFSS are the pyramidal, cerebellar, brain stem, sensory, bowel/bladder, visual, cerebral, and other functions. In addition to the functional system rating scales, there are 2 additional questions asking about weakness and temporal pallor, which could affect the ratings.

The Kurtzke Functional Systems Scores (KFSS) and Kurtzke Expanded Disability Status Scale (EDSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator and results from this assessment are then applied to determine an EDSS scale score (Kurtzke, 1983). A change in the EDSS should only occur if there has been a change of one or more in the Functional System (FS) scores. Please review the published Kurtzke Expanded Disability Status Scale (EDSS) for details on the related EDSS score.

  1. For each functional system of the KFSS, the scale points include a numeric rating and a definition of what is represented by the rating (e.g., 0 = “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating. For the KFSS, for functional systems with a numeric rating, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN. Otherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.

  2. Some responses to the KFSS items exceeded the 200-character limit for the RSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit. For item KFSS104, one of the rating responses is longer than the 200 character limit.

  3. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (e.g., weakness, temporal pallor). RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”. RSSTRESN is always left blank.

  4. When RSTESTCD = "KFSS108"  is not answered, the result is considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”. Item RSTESTCD = "KFSS108A" will only be answered if RSTESTCD = "KFSS108" has a RSORRES = “Any other neurologic findings attributed to MS (specify)”, otherwise it will be considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”.  

  5. Terminology:
    1. RSCAT, RSTESTCD, and RSTEST are approved CDISC controlled terminology.
    2. A full list of value sets for result fields is provided in Section 4: SDTM Mapping Strategy.

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